Senior Manager, Regional Clinical Trial Manager

  • Contract
  • Japan



The Role:

Clinical Trial Manager to be part of our Clinical Operation team.

This position is based in our Tokyo office.

As Clinical Trial Manager, you will be part of a dedicated team local and global team and will be operationally responsible for the planning, start-up, conduct and closure of clinical trials in Japan constitute with your knowledge and experience.

It works closely together with the global Clinical Trial Managers with the oversight activities across Genmab clinical trials in Japan, as applicable.


Key responsibilities include but are not limited to:

  • Co-leads and/or support the cross-functional Japan trial-specific Clinical Management Team (CMT), including the CROs, to deliver clinical trials within budget and timelines and according to quality standards defined by regulations, Genmab SOPs, Japan Good Clinical Practice guidelines and ICH-GCP. It is responsible for coordinating and challenging the various CROs/CMT members’ efforts and their functions related to the clinical trial to deliver quality trials within timelines and budget.
  • It is responsible for ensuring appropriate involvement of and communication with relevant stakeholders.
  • If assigned but not leading the trial, the role is to support and collaborate with the global CTM (Clinical Trial Manager) with the efficient planning, conducting and reporting of the trial.
  • The Clinical Trial Manager will ensure regular communication and agreement with global counterpart regarding strategy and execution of trials, including trouble shooting and functional support, as applicable.
  • It also acts as a functional leader for Japan and will also create corresponding strategy for the trial execution in alignment with Japan R&D and Global Clinical Operations, and other global teams (i.e. CDT), as applicable.
  • Collaborate cross-functionally with other R&D functions both at local and global level for clinical trials in Japan.


Moreover, you meet the following professional requirements:

  • A BSc or MSc level preferably within the medical, biological, pharmaceutical science or equivalent discipline
  • Minimum of 8 years of experience monitoring clinical trials. It would be even better to have experience in the oncology
  • Proven skills from working in a project oriented and international organization
  • Good oral and written communication skills
  • Ability to travel to field sites
  • Business level English in verbal, reading, & writing
  • Native level Japanese in verbal, reading, & writing




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